Patient Navigation for Colorectal Cancer Screening for Patients With Mental Illness and/or Substance Use Disorder

Mass General Brigham

Status: Completed

Conditions: ColoRectal Cancer Screening

Treatments: Behavioral: patient navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT03244787

2016P001322

Details and patient eligibility

About

The investigators propose to develop, implement, and evaluate a novel Colorectal (CRC) screening patient navigator program for patients with Mental Health (MH) and /or Substance Use Disorder (SUD) receiving care at Massachusetts General Hospital Charlestown. The study will involve randomly assigning eligible patients to early intervention or usual care/delayed intervention groups. The investigators believe this random assignment is ethical because Patient Navigation (PN) is an extremely limited resource, and all patients identified as eligible could not be contacted by the navigators in a short period of time. Thus the investigators will randomly assign access to PN during the study period, and then allow all patients to be navigated and screened after the study period is over. As a result, all eligible patients will be referred for PN, but the timing of the referral will be randomly assigned.

Enrollment: 380 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adult patients aged 50-75 years who are not up to date on CRC screening (did not have had CRCs colonoscopy in the last 10 years or sigmoidoscopy in the last 5 years or fecal occult blood within last 12 months)
• receive care at MGH Charlestown
• have documented history of MH or SUD in electronic medical record

Exclusion criteria

• subsequently identified as having died prior to study intervention
• patients with total colectomy

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 2 patient groups

patient navigation

Experimental group

Description:

PN will contact patients during their visits to health cancer or over the phone. During this initial contact, the PN will educate patients about CRC, screening and explore their barriers to screening. The PN will coordinate scheduling of CRC screening and remind patients about the tests. PN will explain preparation for colonoscopy and whenever feasible, accompany patient to obtain the test. Further interventions may include: reminding the patient about the test, helping with translation, insurance issues, transportation, and overcoming any other system barriers as needed.

Treatment:

Behavioral: patient navigation

usual care

No Intervention group

Description:

patients randomly assigned to the control will receive usual care and be eligible for navigation after the study period.